Weight change after smoking cessation using variable doses of transdermal nicotine replacement.

Objective: Examine weight change in subjects receiving variable doses of transdermal nicotine replacement for smoking cessation.
Design: Randomized, double-blind clinical trial.
Setting: One-week inpatient treatment with outpatient follow-up through 1 year.
Intervention: This report examines weight change after smoking cessation for 70 subjects randomized to placebo or to 11, 22, or 44 mg/d doses of transdermal nicotine. The study included 1 week of intensive inpatient treatment for nicotine dependence with active patch therapy continuing for another 7 weeks. Counseling sessions were provided weekly for the 8 weeks of patch therapy and with long-term follow-up visits at 3, 6, 9, and 12 months.
Measurements and Main Results: Forty-two subjects were confirmed biochemically (i.e., by expired carbon monoxide) to be nonsmokers at all weekly visits during patch therapy. Their 8-week weight change from baseline was 3.0 +/- 2.0 kg. For these subjects, 8-week weight change was found to be negatively correlated with percentage of cotinine replacement (r = -.38, p = .012) and positively correlated with baseline weight (r = .48, p = .001), and age (r = .35, p = .025). Men had higher (p = .003) 8-week weight gain (4.0 +/- 1.8 kg) than women (2.1 +/- 1.7 kg). Of the 21 subjects who abstained continuously for the entire year, 20 had their weight measured at 1-year follow-up. Among these 20 subjects, 1-year weight change was not found to be associated with gender, baseline weight, baseline smoking rate, total dose of transdermal nicotine, or average percentage of cotinine replacement during the 8 weeks of patch therapy.
Conclusions: This study suggests that higher replacement levels of nicotine may delay postcessation weight gain. This effect is consistent for both men and women. We could not identify any factors that predict weight change with long-term abstinence from smoking.